The primary objective of this study is to assess the efficacy of rifaximin SSD versus placebo in preventing complications of liver cirrhosis, such as all-cause mortality (death due to all causes) or hospitalization, in subjects with early decompensated liver cirrhosis. Rifaximin, a non-systemic antibacterial agent, is currently marketed as a 550 mg tablet for the reduction in risk of recurrent overt hepatic encephalopathy, a complication of liver cirrhosis. The rifaximin SSD tablet was formulated to maximize the efficacy of rifaximin. Subjects will receive 1 of 5 doses of rifaximin SSD tablets or placebo tablets every day for 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
420
Salix Investigative Site
Birmingham, Alabama, United States
Salix Investigative Site
Dothan, Alabama, United States
Salix Investigative Site
Mobile, Alabama, United States
Salix Investigative Site
Tucson, Arizona, United States
Salix Investigational Site
Artesia, California, United States
Time to all-cause mortality or hospitalization that is attributable to complications of liver disease.
The primary outcome measure will evaluate the time from start of the treatment period to death due to any cause (all-cause mortality) or hospitalization due to complications of liver disease for each patient during the 24-week treatment period.
Time frame: Weeks 1 through 24
Overall hospitalization rate due to each complication of liver disease or all-cause mortality over the 24-week treatment period.
This outcome measure will determine the rate of hospitalization (percentage of patients who are hospitalized) due to each complication of liver disease or all-cause mortality over the 24-week treatment period.
Time frame: Weeks 1 through 24
Pharmacokinetics of rifaximin and its metabolite.
This outcome will measure the plasma levels of rifaximin and its metabolite (25-desacetyl rifaximin) for each patient during the 24-week treatment period.
Time frame: Weeks 1 through 24
Incidence of treatment-emergent adverse events.
This outcome will evaluate the incidence of treatment-emergent adverse events (percentage of patients who experience adverse events following the start of the treatment period).
Time frame: Weeks 1 through 24
Change in clinical laboratory parameters.
This outcome will measure the changes in each patient's clinical laboratory test results during the treatment period.
Time frame: Weeks 1 through 24
Changes in electrocardiogram measurements
This outcome will measure the changes in measurements obtained from 12-lead electrocardiograms for each patient during the treatment period.
Time frame: Weeks 1 through 24
Changes in indices of health outcomes
This outcome will evaluate each patient's responses on questionnaires that assess health status.
Time frame: Weeks, 4, 8, 12, 16, and 24
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Salix Investigational Site
Bakersfield, California, United States
Salix Investigational Site
Chula Vista, California, United States
Salix Investigational Site
Coronado, California, United States
Salix Investigational Site
Costa Mesa, California, United States
Salix Investigative Site
Fresno, California, United States
...and 110 more locations